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Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia | Clinical Trials | Clareo Health

COMPLETEDNA

Study of Insulin Pump in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia

Study of Minimed 640G Insulin Pump With SmartGuard in Prevention of Low Glucose Events in Adults With Type 1 Diabetes at Risk of Severe Hypoglycemia

NCT02657213•University Hospital, Grenoble

View on ClinicalTrials.gov

Summary

The main objective is to evaluate the efficacy of sensor augmented pump (SAP) therapy with MiniMed 640G with SmartGuard activation in preventing hypoglycemia events in comparison sensor augmented pump (SAP) therapy with Minimed 640G without SmartGuard activation in type 1 diabetic adults with an increased risk of hypoglycemia. The study should show: * A reduction in the number of severe hypoglycemia, fewer hypoglycemic events and a reduction in the time spent in hypoglycemia six months in any group compared to Baseline. * A complete prevention of severe and not severe hypoglycemia in the pump group Minimed 640G + Enlite sensor with SmartGuard activation

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Type 1 or insulin-dependent diabetic patients
•Patients treated with subcutaneous insulin pump with at least 2 episodes of severe hypoglycemia within 12 months before the study enrollment
•Affiliation to the french social security system or equivalent
•People who signed the consent form

Exclusion Criteria

•Patient who have difficulty to understand the French language
•Patient can not be raised to the use of an insulin pump, or a glucose sensor
•Patient visually impaired
•Patient hard of hearing
•Pregnant woman or woman having a project of pregnancy within 6 months
•Persons referred to in Articles L1121-5 to L1121-8 CSP: pregnant woman, woman in labor, breastfeeding women, persons deprived of their liberty by judicial or administrative decision, person under a legal protection measure.

Locations (2)

Grenoble University Hospital

Grenoble, France

Montpellier University Hospital

Montpellier, France

Key Dates

Start Date

February 1, 2016

Primary Completion Date

June 1, 2017

Completion Date

June 1, 2017

Last Updated

October 18, 2017

Enrollment

ACTUAL participants

Conditions

Diabetes, Type 1

Interventions

Minimed 640G with smartguard activated

DEVICE

Minimed 640G with smartguard off

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 18, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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